Established and led a process focused Software QA organization, successfully implementing the SQA function across multiple sites in the United States. Significantly reduced software development cycle times and defects.

Led a team of senior software managers in defining and implementing a Divisional Software.

Development process for medical device software that complies with FDA and ISO regulations.

Led the implementation of a divisional non-product software life cycle process with the goal of reducing cycle time.

Led a team of senior IT professionals in the assessment and remediation of computerized systems for compliance to FDA 21CFR Part 11. Established system level requirements to ensure consistent and sustained compliance.

Designed and developed real-time embedded software for a therapeutic drug monitoring analyzer.

Developed and presented a high volume abused drug detection system to the United States Department of Defense. Installed and ran computer systems during on site evaluation. Conducted site inspections to ensure successful system installation.

Defined and implemented diagnostics software metrics program, which led to a significant reduction in emergency software releases due to escaping software defects.

Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations.

Developed system level validation plans and protocols for both internally and externally developed laboratory management systems.

Contributed to successful ISO 9001 and 9000-3/TicKIT certifications for the site.